Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Clinical Trial in Houston, TX

Q: Is NCT03263572 recruiting in Houston, TX?

Yes, NCT03263572 is currently recruiting participants at its Houston, TX location. This accelerated phase chronic myelogenous leukemia, bcr-abl1 positive clinical trial is actively enrolling qualified participants.

Q: How do I join the accelerated phase chronic myelogenous leukemia, bcr-abl1 positive clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Study in Houston

This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Diagnosis of one of the following:

Participants ≥ 18 years of age with previously untreated Ph-positive ALL \[either t(9;22) and/or BCR-ABL positive\] (includes patients initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. These participants could have received one or two courses of chemotherapy with or without other TKIs and still eligible. (Participants with lymphoid accelerated or blast phase CML will be evaluated separately) i. If they achieved CR, they are assessable only for event-free and overall survival, or ii. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival

Participants ≥ 18 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)

Participants ≥ 18 years of age with ALL MRD positive (either by NGS or PCR or flowcytometry) or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)

Performance status ≤ 2 (ECOG Scale)

Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):

Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome

Alanine aminotransferase (ALT) ≤ 3 x ULN, OR

Aspartate aminotransferase (AST) ≤ 3 x ULN

Adequate pancreatic function as defined by the following criteria: a) Serum lipase and amylase ≤ 1.5 x ULN

For females of childbearing potential, a negative urine pregnancy test must be documented

Female participants who:

Are postmenopausal for at least 1 year before the screening visit, OR

Are surgically sterile, OR

If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse

Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:

Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or

Agree to completely abstain from heterosexual intercourse

Adequate cardiac function as assessed clinically by history and physical examination.

Signed informed consent

Exclusion Criteria

Active serious infection not controlled by oral or intravenous antibiotics.

History of acute pancreatitis within 1 year of study or history of chronic pancreatitis

History of alcohol abuse

Uncontrolled hypertriglyceridemia (triglycerides \> 650mg/L)

Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.

Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.

Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:

Myocardial infarction (MI), stroke, or revascularization within 3 months

Unstable angina or transient ischemic attack

Congestive heart failure prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment

Diagnosed or suspected congenital long QT syndrome

Clinically significant atrial or ventricular arrhythmias (such as artrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician

Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist

Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility.

Uncontrolled hypertension (diastolic blood pressure \>90mmHg; systolic \>140mmHg). Participants with hypertension should be under treatment on study entry to effect blood pressure control

History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade 3 or above) CNS events including ICANS from prior CART or other T cell engager therapies. Participants with active CNS leukemia - will NOT be excluded

Current autoimmune disease or history of autoimmune disease with potential CNS involvement

Treatment with any investigational antileukemic agents or chemotherapy agents within 2 weeks prior to study entry, unless full recovery from side effects has occurred or participant has rapidly progressive disease judged to be life-threatening by the investigator.

Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.

History of significant bleeding disorder unrelated to cancer, including:

Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)

Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.

Known active infection with HIV, HBV, HCV.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT03263572) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Treatment Options in Houston, TX

If you're searching for accelerated phase chronic myelogenous leukemia, bcr-abl1 positive treatment options in Houston, TX, this clinical trial (NCT03263572) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced accelerated phase chronic myelogenous leukemia, bcr-abl1 positive specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all accelerated phase chronic myelogenous leukemia, bcr-abl1 positive clinical trials near you to find additional studies recruiting in your area.

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Clinical Trial in Houston, TX

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